MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the 2nd of 2 reports.Subject device remains implanted.
Event or Problem Description
During treatment of anterior cerebral artery (aca) aneurysm, it was reported that the aneurysm ruptured after the deployment of the 5th coil (subject device).A compliant balloon was placed and inflated in the right a1 segment and heparin was reversed to treat the rupture.The 6th coil was deployed and detached without issue.When the 7th coil was deployed, an approximately 1cm of the coil tail migrated into the left a2 segment.At that time, no suitable retrieval devices were available, so the decision was made to deploy a stent to secure the subject coil tail.Thrombus formation was noted within the stent and the right a2 segment.The patient was administered with iv aspirin and reopro with good result.The patient was kept in icu overnight and is being slowly woken throughout the day today.No further information is available at this time.
Additional Manufacturer Narrative
Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.Based upon medical review assessment, the data reasonably suggest the clinical event is anticipated in nature and severity as per the dfu and does not require escalation to senior management.An assignable cause of anticipated procedural complication, will be assigned to the reported patient aneurysm rupture, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
During treatment of anterior cerebral artery (aca) aneurysm, it was reported that the aneurysm ruptured after the deployment of the 5th coil (subject device).A compliant balloon was placed and inflated in the right a1 segment and heparin was reversed to treat the rupture.The 6th coil was deployed and detached without issue.When the 7th coil was deployed, an approximately 1cm of the coil tail migrated into the left a2 segment.At that time, no suitable retrieval devices were available, so the decision was made to deploy a stent to secure the subject coil tail.Thrombus formation was noted within the stent and the right a2 segment.The patient was administered with iv aspirin and reopro with good result.The patient was kept in icu overnight and is being slowly woken throughout the day today.No further information is available at this time.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9175421
• Report Number: 3008881809-2019-00308
• Device Sequence Number: 14155981
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: M0035474100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 46 YR